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Search / Trial NCT07057817

The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb Salvage

Launched by ROYAL COLLEGE OF SURGEONS, IRELAND · Jun 30, 2025

Trial Information

Current as of July 14, 2025

Not yet recruiting

Keywords

Calcanectomy Eq5d5l

ClinConnect Summary

The ACHILLS Trial is a research study looking at a new way to help heal infections in the heel bone, especially for people with diabetes who need part of their heel bone removed (a surgery called partial calcanectomy). The study is testing whether using a special antibiotic bone graft called Cerament G helps wounds heal better and lowers the chance of the infection coming back, compared to surgery without this graft. The trial will include about 30 patients and follow them for one year to see how well they recover.

People who are 18 or older, have diabetes (type 1 or 2), and need partial calcanectomy surgery might be able to join the study. Before joining, doctors will check things like blood flow to the leg and kidney function to make sure it’s safe. Participants can expect to have the surgery with or without the antibiotic bone graft and will be closely monitored over the next year to see how their wound heals and if the infection returns. This study is not yet open for enrolling patients but aims to find better ways to save the lower leg and avoid more serious amputations.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 18 and over
  • Undergoing partial calcanectomy
  • Patients with Type1 or Type 2 Diabetes
  • Patients will be stratified by Pulse status and eGFR
  • Exclusion Criteria:
  • Patients unfit for surgery
  • Patients unable to provide informed consent
  • Patients with overwhelming sepsis that require major amputation
  • Patients with hypersensitivity to aminoglycosides
  • Pre-existing calcium metabolism disorder
  • Severe renal impairment
  • Patients in whom major limb amputation is deemed inevitable by the treating physician

About Royal College Of Surgeons, Ireland

The Royal College of Surgeons in Ireland (RCSI) is a prestigious educational and research institution dedicated to advancing surgical practice and healthcare through innovative research, education, and clinical excellence. As a clinical trial sponsor, RCSI plays a pivotal role in conducting cutting-edge research that aims to improve surgical outcomes and patient care. With a commitment to fostering collaboration among healthcare professionals, researchers, and industry partners, RCSI is at the forefront of developing evidence-based interventions and therapies that address critical health challenges. Through its rigorous scientific approach and adherence to ethical standards, RCSI strives to contribute significantly to the advancement of medical knowledge and the enhancement of surgical practices globally.

Locations

Galway, , Ireland

Patients applied

0 patients applied

Trial Officials

James Walsh

Principal Investigator

Beaumont Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported